Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for AR101, an investigational biologic oral immunotherapy to reduce the frequency and severity of allergic reactions following exposure to peanuts in children and adolescents ages 4 to 17.
“This is an important milestone for us as a company, as well as for people across Europe living with peanut allergy, a growing worldwide health problem that significantly affects the quality of life of both patients and their families,” said Jayson Dallas, M.D., President and Chief Executive Officer of Aimmune. “We are continuing to expand our organization across Europe to prepare for potential approval of AR101 in key markets and engaging in reimbursement discussions to expedite access for patients upon approval.”
The MAA submission includes extensive data from the only Phase 3 clinical trial program to meet the primary endpoints in children and teens with peanut allergy. This program included well over 1,000 patients enrolled into the PALISADE, RAMSES and ARTEMIS trials. The pivotal European Phase 3 ARTEMIS study, which represents a key component of the MAA submission, reinforced the consistent clinical profile of AR101 after six months of dose escalation and a three-month therapeutic dosing phase. The ARTEMIS trial enrolled 175 peanut-allergic children and adolescents ages 4 to 17 from 18 sites in France, Germany, Ireland, Italy, Spain, Sweden and the United Kingdom.
A Biologics License Application (BLA) seeking approval for AR101 for the treatment of children and adolescents with peanut allergy currently is under review by the U.S. Food and Drug Administration (FDA), which is expected to take until late January 2020. The Allergenic Products Advisory Committee (APAC) of the FDA will review the BLA for AR101 at its meeting scheduled for September 13, 2019.
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